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Sponsored by: |
MedtronicNeuro |
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Information provided by: | MedtronicNeuro |
ClinicalTrials.gov Identifier: | NCT00200083 |
The purpose of this study is to test the effect of an implanted device that stimulates the stomach to help obese patients lose weight.
Condition | Intervention |
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Obesity Morbid Obesity |
Device: Transcend II Model 8848 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | SHAPE: Screened Health Assessment & Pacer Evaluation |
Enrollment: | 190 |
Study Start Date: | May 2004 |
Study Completion Date: | January 2008 |
Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
All subjects enrolled will be implanted with an IGS system. The active group are those randomized to "on" and will receive active stimulation for 12 months.
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Device: Transcend II Model 8848
All subjects will be implanted with the IGS device and then randomized to "on" or "off" for 12 months. After 12 months all subjects will be turned "on" through 24 month follow up.
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B: Placebo Comparator
All subjects enrolled will be implanted with an IGS system. The placebo group are those randomized to "off" and will receive no stimulation for 12 months.
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Device: Transcend II Model 8848
All subjects will be implanted with the IGS device and then randomized to "on" or "off" for 12 months. After 12 months all subjects will be turned "on" through 24 month follow up.
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The purpose of this study was to evaluate efficacy and safety of the IGS system in a population of patients with a BMI between 35 and 55 kg/m2.
SHAPE was a randomized, placebo-controlled, double-blind, multi-center pivotal study in which all subjects were implanted with the IGS system.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, District of Columbia | |
Contact Medtronic for specific site information | |
Washington, District of Columbia, United States, 20037 | |
United States, Florida | |
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Gainsville, Florida, United States, 32611 | |
United States, Illinois | |
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Chicago, Illinois, United States, 60611 | |
United States, Massachusetts | |
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Boston, Massachusetts, United States, 02111 | |
United States, Minnesota | |
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Minneapolis, Minnesota, United States, 55416 | |
United States, Missouri | |
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St. Louis, Missouri, United States, 60611 | |
United States, New York | |
Contact Medtronic for specific site information | |
New York, New York, United States, 10032 | |
United States, Pennsylvania | |
Contact Medtronic for specific site information | |
Philadelphia, Pennsylvania, United States, 19140 |
Study Chair: | Obesity Study Team Obesity Study Team | Medtronic |
Responsible Party: | Clinical research specialist ( Medtronic Inc ) |
Study ID Numbers: | 95-2002-015 |
Study First Received: | September 12, 2005 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00200083 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Obesity Morbid Obesity SHAPE IGS Implantable Gastric Stimulator |
Body Weight Signs and Symptoms Obesity Weight Loss |
Nutrition Disorders Overweight Overnutrition Obesity, Morbid |
Body Weight Signs and Symptoms Obesity Nutrition Disorders |
Overweight Overnutrition Obesity, Morbid |